(112 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
This document describes the FDA 510(k) clearance for "Nitrile examination gloves" (K211927). The clearance is based on substantial equivalence to a predicate device (K203593). The device is a non-sterile, powder-free, single-use examination glove made of nitrile rubber.
The key acceptance criteria for this device are defined by a set of ASTM and ISO standards, which dictate the physical properties, freedom from holes, powder residue, and biocompatibility of the gloves.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Standard | Reported Device Performance (K211927) | Predicate Device Performance (K203593) |
|---|---|---|---|
| Dimensions (Palm Width) | ASTM D6319-19 | XS (70±10mm) | |
| S (80±10mm) | |||
| M (95±10mm) | |||
| L (110±10mm) | |||
| XL (120±10mm) | Small (80±10mm) | ||
| Medium (95±10mm) | |||
| Large (110±10mm) | |||
| X large (120±10mm) | |||
| Dimensions (Length) | ASTM D6319-19 | XS (220mm min) | |
| S (220mm min) | |||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | S (220mm min) | ||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | |||
| Thickness | ASTM D6319-19 | Palm: 0.05mm min | |
| Finger: 0.05mm min | Palm: 0.05mm min | ||
| Finger: 0.05mm min | |||
| Freedom from holes | ASTM D5151-06 | Free from holes when tested (Pass) | Free from holes when tested (Pass) |
| Physical Properties (before aging) | ASTM D6319-19 | Tensile Strength: 14MPa, min | |
| Ultimate Elongation: 500% min | Tensile Strength: 14MPa, min | ||
| Ultimate Elongation: 500% min | |||
| Physical Properties (after aging) | ASTM D6319-19 | Tensile Strength: 14MPa, min | |
| Ultimate Elongation: 400% min | Tensile Strength: 14MPa, min | ||
| Ultimate Elongation: 400% min | |||
| Powder Residual | ASTM D6124 | ≤2.0 mg/gloves | ≤2.0 mg/gloves (implied by "Same" discussion) |
| Biocompatibility - Skin Sensitization Test | ISO 10993-10 | Not a sensitizer (Pass) | Not a sensitizer (Pass) |
| Biocompatibility - Skin Irritation Test | ISO 10993-10 | Not an irritant (Pass) | Not an irritant (Pass) |
| Biocompatibility - Cytotoxicity Test | ISO 10993-5 | Non-cytotoxic to L-929 cells (Pass) | Cytotoxicity assessed via rationale (Pass) |
| Shelf-life | Not specified in table | 3 years | 3 years |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of gloves tested for tensile strength, number of samples for biocompatibility). The studies are non-clinical (laboratory testing) and based on internationally recognized standards (ASTM, ISO). The data provenance is from the manufacturing site in Guangdong, China, as indicated by the submitter's address. The tests are prospective as they were performed to verify the device met specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for these tests isn't established by human experts in the sense of clinical diagnosis (e.g., radiologists). Instead, the performance is measured against objective, validated scientific standards (ASTM, ISO) and laboratory methods. The "experts" would be the qualified laboratory personnel performing the standardized tests, but their number and specific qualifications are not detailed in this submission.
4. Adjudication method for the test set
This is not applicable. The device performance is determined by meeting objective criteria defined in the referenced ASTM and ISO standards, not by an adjudication process typically used for human-reviewed data or clinical outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. Nitrile examination gloves are a physical medical device, not a diagnostic AI/imaging product. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical glove, not an algorithm or AI.
7. The type of ground truth used
The "ground truth" for this device is based on objective, standardized measurements and laboratory tests defined by ASTM and ISO standards. This includes:
- Physical measurements: Dimensions (palm width, length, thickness) measured according to ASTM D6319-19 and ASTM D3767-03(2020).
- Performance testing: Freedom from holes (ASTM D5151-19), tensile strength and ultimate elongation before and after aging (ASTM D6319-19, ASTM D412-16, ASTM D573-04(2019)), and powder residual (ASTM D6124-06(2017)).
- Biocompatibility testing: Skin sensitization, skin irritation (ISO 10993-10: 2010), and in vitro cytotoxicity (ISO 10993-5: 2009).
8. The sample size for the training set
This is not applicable. There is no "training set" for physical medical devices like examination gloves. The testing is for validation of the final product specifications against established standards.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for this type of device, the concept of establishing ground truth for a training set does not apply.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.